Status:
COMPLETED
Endoscopic Therapy of Early Cancer in Barretts Esophagus
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Early Stage Esophageal Adenocarcinoma
Barrett Esophagus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is being done to see if treatment for esophageal cancer can be done using endoscopy for patients ineligible for surgical or radiological therapy. The standard method of treating this type o...
Detailed Description
Participant visit requirements: Screening visit which will last 1 - 2 days, if assigned to photodynamic therapy, there will be a 3 day visit for treatment. Participants must return for a 1 day visit e...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Non-recurrent adenocarcinoma in Barrett's Esophagus confirmed by two experienced gastrointestinal pathologists
- No evidence of submucosal invasion
- No evidence of metastatic disease in either regional or distal lymph nodes, or other organs
- Pre-entry CT scans of the upper abdomen and chest and Endoscopic Ultrasound (EUS) of the tumor and regional lymph nodes are required. Fusion PET scans are suggested for any indeterminate lesions
- Zubrod Performance Status 0-1
- Participants must be have oral intake of greater than 1700 calories a day
- Patient must not have had a second malignancy, other than curable non-melanoma skin cancer or cervical cancer in situ, unless disease free for greater than or equal to 3 years and deemed cured by their hematologist and/or oncologist
- Staging procedures should be performed prior to study entry
- All patients or legally authorized representative must sign a study-specific informed consent prior to randomization.
- Exclusion criteria:
- Prior major esophageal surgery
- Patients who are unable to tolerate endoscopic procedures
- Due to the possible toxic effects of photodynamic therapy and endoscopic sedation to embryos, pregnant or lactating women or men unable or unwilling to practice contraception are excluded
- Patients with an uncontrolled diabetes, heart disease, or hypertension
- Patient and/or legally authorized representative who are unable to comprehend the study requirements or who are not likely to comply with the study parameters.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00217087
Start Date
September 1 2005
End Date
June 1 2012
Last Update
December 24 2015
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905